Cardiac harness delivery device and method

ABSTRACT

The apparatus includes and elongate body having a proximal portion and a distal portion. The body includes a cavity sized to contain a cardiac harness in a compacted configuration and also includes a plurality of elongate push rods movable with respect to the body. The cardiac harness is releasably connected to each of the push rods such that advancement of the push rods in a distal direction moves the harness from a compacted configuration, within the cavity, to an expanded configuration, outside the cavity. The apparatus also includes a releasing member for releasing the connections between the push rods and the harness upon actuation of the releasing member by a user.

RELATED APPLICATIONS

The present application is related to, and claims priority from, U.S.Provisional Patent Application No. 60/427,079, filed Nov. 15, 2002, theentirety of which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a device and method fordelivering a cardiac harness onto the heart of a patient.

2. Description of the Related Art

Congestive heart failure (“CHF”) is characterized by the failure of theheart to pump blood at sufficient flow rates to meet the metabolicdemand of tissues, especially the demand for oxygen. It has beendetermined that a passive wrap, or cardiac harness, may increase theefficiency of a heart affected by congestive heart disease. Whileadvances have been made in cardiac harness technology, a satisfactorydevice and method for delivering and positioning the cardiac harnessonto a patient's heart has yet to be provided.

In one method, access to a patient's heart is achieved through an openchest procedure, wherein the sternum is split and separated to allowaccess to the heart. The cardiac harness is then positioned over theheart by manual manipulation. Such an open chest procedure is highlytraumatic to the patient and, thus, remains a relatively undesirableoption for cardiac harness delivery.

Present cardiac harness delivery devices do not both adequately retainthe cardiac harness onto the delivery device and permit the harness tobe easily released from the delivery device. For example, one deliverydevice utilizes sutures positioned around a circumference of the cardiacharness to secure it to the delivery device. Such arrangements renderthe cardiac harness difficult to release from the delivery device,especially on the rearward side of the heart. This is because thesutures have to be severed in order to release the cardiac harness fromthe delivery device. Such an arrangement would not be well suited for aminimally invasive procedure because an additional instrument would haveto be introduced to sever the sutures. Furthermore, attaching thecardiac harness to the delivery device only along a circumference tendsto apply a localized load to the cardiac harness, which may cause damageto the device.

SUMMARY OF THE INVENTION

Accordingly, a need exists for a cardiac harness delivery device thatovercomes the disadvantages of the prior art. Preferably, the deviceallows release of the cardiac harness from a remote location.Accordingly, a preferred delivery device is configured, in oneorientation, to support the cardiac harness in a compacted configurationto permit minimally invasive delivery of the cardiac harness through arelatively small incision in the patient. Preferably, the deliverydevice includes a plurality of push rods and the cardiac harness issecured to each push rod at at least two spaced apart locations along alongitudinal axis of the push rod. Accordingly, with such anarrangement, the applied load is spread along the length of the cardiacharness, thereby reducing the possibility of damaging the harness duringdelivery.

In accordance with another embodiment, the present invention involves anapparatus for delivering a cardiac harness, wherein the apparatusincludes a support member. The cardiac harness is preloaded on thesupport member and attached to the support member by a line. The line iscomprised of a series of interconnected loops, which form a releasablestitch.

In a further embodiment, the present invention involves an apparatus fordelivering a cardiac harness including an elongate body having aproximal portion and a distal portion. The body has a cavity sized tocontain the harness in a compacted configuration. A plurality ofelongate push rods are longitudinally movable with respect to the body.The cardiac harness is releasably connected to each of the push rodssuch that advancement of the push rods in a distal direction moves theharness from the compacted configuration in the cavity to an expandedconfiguration outside the cavity. The apparatus also includes areleasing member which releases the connections between the push rodsand the harness upon actuation of the member by a user.

Yet another embodiment of the present invention involves an apparatusfor delivering a cardiac harness including an elongate body having aproximal portion and a distal portion. The apparatus also includes aplurality of push rods longitudinally movable with respect to the body.The cardiac harness is releasably connected to each of push rods suchthat movement of the push rods in a distal direction advances theharness onto a heart of a patient. The harness is releasable from thepush rods such that the push rods may be withdrawn from the harnessproximally along a withdrawal path while the harness remains on theheart. The distal portion of the push rods have an inward facing surfacewhich presses against the harness during the withdrawal. The inwardfacing surface is configured such that nonfrictional force componentsparallel to the withdrawal path and attributable to forces exerted bythe inner surface on the harness are directed distally, withoutsubstantial nonfrictional force components being directed proximally.

Still another embodiment of the present invention involves a method ofdelivering a cardiac harness including providing a cardiac harness whichis preloaded on a support member. The harness is attached to the supportmember by a line forming a releasable stitch. The method furtherincludes positioning the harness so that the harness surrounds a portionof a heart of a patient, and disconnecting the harness from the supportmember by releasing the releasable stitch without cutting the line.

A further embodiment of the present invention involves an apparatus forcreating a passage through the pericardium of a patient to permit accessof a cardiac harness delivery device to the heart. The apparatusincludes an introducer sleeve and a dilator sleeve. The introducersleeve has an outer wall defining a proximal end and a distal end. Theouter wall has a reduced diameter portion adjacent the distal end. Thereduced diameter portion defines a reduced orientation having a firstdiameter. The dilator sleeve is sized and shaped to be insertable intothe introducer sleeve to urge the reduced diameter portion into anexpanded orientation having a second diameter, larger than the firstdiameter. The second diameter is of a size sufficient to permit theapparatus to pass therethrough.

A still further embodiment of the present invention involves anapparatus for assisting the loading of a cardiac harness onto a deliverydevice having a plurality of elongated push rods. The apparatus includesan outer wall defining a generally funnel shaped portion. The funnelshaped portion includes a plurality of channels configured to receivethe plurality of elongated push rods. The outer wall is configured tosupport the push rods in an outwardly splayed orientation.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentinvention are described with reference to drawings of a preferredembodiment, which are intended to illustrate, but not to limit, thepresent invention. The drawings contain 27 figures.

FIG. 1 is a perspective view of a cardiac harness delivery deviceconstructed in accordance with certain features, aspects and advantagesof the present invention. The illustrated delivery device comprises abody portion, including an elongate shaft and a housing, and a movableportion, including a control assembly and a plurality of elongate pushrods. A cardiac harness is carried by distal end portions of theplurality of push rods.

FIG. 2 is an enlarged, partial cutaway view of a distal portion of thedelivery device of FIG. 1 showing the cardiac harness in a compactedconfiguration within a cavity defined by the housing.

FIG. 3 is a perspective view of the delivery device of FIG. 1 with themovable portion in an advanced position relative to the body portion.

FIG. 4 is an enlarged view of a distal portion of the delivery device ofFIG. 1 indicated by line 4-4 of FIG. 3.

FIG. 5 is a cross-sectional view of one of the plurality of push rodstaken along line 5-5 of FIG. 4. FIG. 5 illustrates a line, forming areleasable stitch, to secure the cardiac harness to the push rod.

FIG. 6 is an enlarged, side view of the control assembly of the deliverydevice of FIG. 1 indicated by line 6-6 of FIG. 3. The illustratedcontrol assembly includes a body portion, a cover and a release member.

FIG. 7 a is a plan view of the body portion of the control assembly ofFIG. 6, taken along line 7-7 of FIG. 6. FIG. 7 a illustrates a pluralityof channels defined by the body portion of the control assembly. Thechannels are configured to receive portions of the line associated witheach push rod.

FIG. 7 b is an enlarged view of the body portion of the control assemblyof FIG. 7 a illustrating the routing of the line portions within thechannels of the control assembly.

FIG. 7 c is an enlarged view of the arrangement of FIG. 7 b, showing arelease member being pulled away from a body portion of the controlassembly.

FIG. 8 is a cross-sectional view of the control assembly of FIGS. 6 and7, taken along line 8-8 of FIG. 7 a.

FIG. 9 is a cross-sectional view of the control assembly of FIGS. 6 and7, taken along line 9-9 of FIG. 7 a.

FIG. 10 is a cross-sectional view of one of the plurality of elongatepush rods, taken along line 10-10 of FIG. 8.

FIG. 11 a is a cross-sectional view of one of the plurality of pushrods, illustrating the releasable stitch of FIG. 5 being unraveled torelease the cardiac harness from the push rod.

FIG. 11 b is a cross-sectional view of the push rod of FIG. 11 a,illustrating the releasable stitch in a further unraveled condition.

FIG. 11 c is a cross-sectional view of the push rod of FIG. 11 a,illustrating the releasable stitch in a substantially releasedcondition.

FIG. 12 is a cross-sectional view of a distal tip of one of theplurality of elongate push rods, taken along line 12-12 of FIG. 4.

FIG. 13 is a side elevational view of an introducer sleeve portion of anintroducer assembly for facilitating introduction of the delivery deviceof FIGS. 1-12 through the pericardium surrounding the heart of apatient.

FIG. 14 is a side elevational view of the introducer assembly,illustrated in an unassembled condition and including the introducersleeve and a dilator sleeve.

FIG. 15 is a side elevational view of the introducer assembly in anassembled condition, with the dilator sleeve disposed within theintroducer sleeve.

FIG. 16 is a perspective view of a heart having a small incision in thepericardium to permit the delivery device to access the heart.

FIG. 17 is a perspective view of the heart of FIG. 16 with theintroducer sleeve of the introducer assembly of FIG. 14 positionedwithin the incision in the pericardium.

FIG. 18 is a perspective view of the heart of FIG. 16 with theintroducer assembly, in an assembled condition, providing an accesspathway through the pericardium for introduction of the delivery device.

FIG. 19 is a side elevational view of the delivery device of FIGS. 1-12,with a pump member, or, specifically, a syringe, attached to a suctionassembly of the delivery device. The suction assembly includes a suctioncup member, which is configured to securely hold the heart relative tothe delivery device during advancement of the cardiac harness over theheart.

FIG. 20 is a side elevational view of the delivery device of FIG. 19with the cardiac harness in a partially advanced position.

FIG. 21 is a side elevational view of the delivery device of FIG. 19with the cardiac harness in a fully advanced position and the releasingmember being actuated to release the cardiac harness from the deliverydevice.

FIG. 22 is a side elevational view of the delivery device of FIG. 19with the cardiac harness being completely released and the plurality ofpush rods being retracted.

FIG. 23 is a side elevational view of the delivery device of FIG. 19with the cardiac harness completely released and illustrating thedelivery device being withdrawn from the heart.

FIG. 24 is a side elevational view of a loading device, configured toassist in loading a cardiac harness to the delivery device.

FIG. 25 is a cross-sectional view of the loading device of FIG. 24,taken along the line 25-25 of FIG. 24.

FIG. 26 is a bottom plan view of the loading device of FIG. 24, takenalong the line 26-26 of FIG. 24.

FIG. 27 is a cross-sectional view of the loading device of FIG. 24illustrating the cardiac harness loaded onto the plurality of push rods.

FIG. 28 a is a cross-sectional view of one of the plurality of push rodsillustrating the formation of an initial loop in the line comprising thereleasable stitch for securing the cardiac harness to the push rod.

FIG. 28 b is a partial cross-sectional view of the push rod of FIG. 28 aillustrating the initial formation of a second loop.

FIG. 28 c is a view of the push rod of FIG. 28 b illustrating he secondloop being passed through the initial loop.

FIG. 29 is a perspective view of another embodiment of a controlassembly.

FIG. 30 is a perspective view of another embodiment of a push rodadapted to be used with the control assembly of FIG. 29.

FIG. 31 is an enlarged view of a distal portion of push rod of FIG. 30taken along line 31-31.

FIG. 32 is cross-sectional view of the push rod of FIG. 30 taken alongline 32-32.

FIG. 33 shows the push rod of FIG. 5, illustrating another embodimentand arrangement of a line forming a releasable stitch to secure acardiac harness to the push rod.

FIG. 34 is a plan view of a body portion of the control assembly of FIG.29.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIGS. 1-11 illustrate a preferred embodiment of a cardiac harnessdelivery device, which is generally referred to by the reference numeral30. In a preferred embodiment, the delivery device 30 is configured toreleasably support a cardiac reinforcement device (CRD), such as acardiac harness, and assist in the advancement of the cardiac harnessover the heart of a patient. Once the cardiac harness is positioned onthe heart, the delivery device 30 preferably is configured to releasethe harness and be retractable without causing undesired shifting of thecardiac harness relative to the heart.

In the illustrated arrangement, the delivery device 30 permits deliveryof a cardiac harness in a minimally invasive manner. That is, preferablythe device 30 permits accurate delivery, positioning, and release of thecardiac harness through a relatively small incision in a patient.However, the preferred, or alternative, embodiments of the deliverydevice 30 may also be used to deliver a cardiac harness in an openchest, or other minimally invasive procedure. Further, an embodimentpreferably is configured to enable indirect visualization of at leastportions of the device 30 during surgery. For example, portions of thedevice may be radiopaque so as to be visualized and guided byfluoroscopy or other methods.

With specific reference to FIG. 1, the illustrated delivery device 30generally includes a body portion comprised of a handle 32 affixed tothe proximal end of a hollow, elongate shaft 34. Preferably, a housing36 is affixed to a distal end of the elongate shaft 34. The illustrateddelivery device 30 also includes a movable portion comprised of acontrol assembly 38 and a plurality of elongate push rods 40. Thecontrol assembly 38 and, thus, the push rods 40, are axially slidablealong the shaft 34.

Preferably, the plurality of push rods 40 extend in a distal directionfrom the control assembly 38 and pass through the housing 36. Withreference also to FIG. 2, a cardiac harness 42 is releasably supportedon the distal end portions of the elongate push rods 40 in a compactedconfiguration within the housing 36. Preferably, the cardiac harness 42comprises an elastic sleeve configured to fit around the heart and toexert a compressive force on the heart. In the illustrated embodiment,the harness 42 comprises several interconnected rows of undulatingelastic members. Preferred cardiac harnesses are described in greaterdetail in U.S. patent application Ser. No. 09/634,043, filed Aug. 8,2000; U.S. application Ser. No. 10/242,016, filed Sep. 10, 2002; U.S.application Ser. No. 10/287,723, filed Oct. 31, 2002; and U.S.Application No. 60/409,113, filed Sep. 5, 2002, the entirety of each ofwhich are incorporated by reference herein. It is to be understood thataspects of the delivery device 30 discussed herein can be used inconnection with several other types of cardiac harnesses.

The term “cardiac harness” as used herein is a broad term that refers toa device fit onto a patient's heart to apply a compressive force on theheart during at least a portion of the cardiac cycle. A device that isintended to be fit onto and reinforce a heart and which may be referredto in the art as a “girdle,” “sock,” “jacket,” “CRD,” or the like isincluded within the meaning of “cardiac harness.”

The control assembly 38 and plurality of push rods 40 are movableaxially with respect to the shaft 34 from the retracted positionillustrated in FIG. 1 to an advanced, or deployed position, asillustrated in FIGS. 3 and 4. Thus, the delivery device 30 is configuredto deploy the cardiac harness 42 from a compacted configuration withinthe housing 36 to an expanded position outside of the housing 36 therebydelivering the cardiac harness 42 onto a heart 43 (FIGS. 3 and 4), as isdescribed in greater detail below.

The handle 32 is fixed to the shaft 34 in the illustrated embodiment.However, it is to be understood that in other arrangements the handle 32may be movable relative to the shaft 34 along with the control assembly38. Additionally, another embodiment may not employ a handle 32.Further, with reference to FIG. 1, a stop 39 preferably is provided onthe shaft 34. The stop 39 comprises a raised portion that engages thecontrol assembly 38 so that the assembly 38 cannot move distally overthe shaft 34 beyond the stop 39. As such, the harness 42 is not advancedtoo far over the heart 43.

With reference again to FIG. 2, the housing 36 preferably is arelatively thin-walled, tubular member. Desirably, the housing 36 issupported substantially concentric with the shaft 34 to define aninterior cavity 44 between an inner surface of the housing 36 and anouter surface of the shaft 34. Preferably, the cavity 44 is sized andshaped to contain the cardiac harness 42 in a compacted configurationtherein.

As indicated above, preferably the device 30 is configured to deliverthe cardiac harness 42 in a minimally invasive procedure. Accordingly, apreferred housing 36 has a nominal outer diameter of less than about 2inches and, more preferably, less than about 1.5 inches. However, inadditional, non-minimally invasive embodiments, the housing 36, ifprovided, may be larger than the values given above. In sucharrangements, the harness 42 may be supported by the device 30 in aconfiguration substantially similar to the configuration of the harness42 when positioned on a heart. That is, the cardiac harness does nothave to be supported in a “compacted” configuration by the device, butmay be supported in a configuration closer to its relaxed size andshape.

In the embodiment shown in FIGS. 1-3, the housing 36 is generallycylindrical. It is to be understood that, in another preferredembodiment, the housing is elliptical. As such, the housing may have amajor axis and minor axis. This configuration may be especiallybeneficial for advancing the housing through body passages havingrelatively narrow clearance, such as advancing the housing between ribs.

With continued reference to FIG. 2, a base portion 46 of the housing 36preferably defines a closed end of the cavity 44 and supports thehousing 36 relative to the shaft 34. The base end 46 may be secured tothe shaft 34 by mechanical fasteners, adhesives or other suitablemethods apparent to one of skill in the art. In one embodiment, the baseend 46 is rotatable relative to the shaft 34. Preferably, the distal endof the housing is open to define an open, distal end of the cavity 44 topermit the cardiac harness 42 to be advanced from the cavity 44.

Preferably, an outer wall 48 of the housing 36 defines a plurality ofchannels 50 (FIG. 4) extending axially throughout the length of thehousing 36. Each of the channels 50 preferably is sized and shaped toslidably receive one of the plurality of push rods 40. Thus, preferably,the number of channels 50 is equal to the number of push rods 40.Further, each channel 50 preferably opens into a cavity 44 along atleast a portion of the length of the channel 50.

In the illustrated embodiment, six push rods 40 and channels 50 areprovided and are substantially equally spaced around the circumferenceof the housing 36. In an additional arrangement, however, the channels50 may be omitted and the push rods 40 may simply be restrained frommoving radially outwardly by the sidewall 48 of the housing 36. Othersuitable arrangements to guide the push rods 40 and house the cardiacharness 42 may also be used.

With continued reference to FIGS. 1-4, the delivery device 30 preferablyincludes a positioning arrangement configured to hold the deliverydevice 30 in a desired position relative to the heart 43. In theillustrated arrangement, the positioning arrangement comprises a suctioncup member 52 supported on a distal end of the shaft 34. A tube 54extends through the shaft 34 and is connected to the suction cup member52. A distal end of the tube 54 opens into an interior space defined bythe suction cup member 52. The proximal end of the tube 54 includes aconnector 58 that allows connection of the tube 54 to a pump member suchas a syringe or other source of vacuum. Accordingly, once the deliverydevice is properly positioned, air may be withdrawn from within the tube54 to create a vacuum condition within the interior space of the suctioncup member 52, thereby permitting the suction cup member 52 to securelyhold the heart of a patient.

A clip 56 secures the tube 54 relative to the handle 32 to prevent theproximal end of the tube 54 from passing through the shaft 34. Thus, theclip 56 also operates to secure the suction cup member 52 to thedelivery device 30. In a preferred embodiment, the tube 54 and suctioncup member 52 are not rigidly affixed to the shaft 34 so that the shaft34 may be moved relative to the tube 54 and suction cup 52. In anotherembodiment, the shaft 34 and a proximal end of the suction cup 52 arethreaded so that the suction cup may be threaded onto the shaft. Instill other embodiments, other structure may be used to releasablyconnect the suction cup to the shaft.

With reference next to FIG. 5, preferably the cardiac harness 42 issecured to a distal end portion of each of the plurality of push rods 40by a line, generally referred to by the reference numeral 60, that isconfigured into a releasable stitch. As shown in FIG. 5, a line 60 a isassociated with one of the plurality of push rods 40 and is arrangedinto a releasable stitch configured to secure the cardiac harness 42 tothe push rod 40. Although not individually illustrated, preferably, eachof a plurality of such lines 60 b-f secure the cardiac harness 42 to acorresponding one of the remainder of push rods 40 in a manner similarto line 60 a, which is illustrated in FIG. 5. Desirably, the line 60 ais arranged into a series of interconnected loops that are releasable byactuation of the control assembly 38 in a manner described in greaterdetail below. Release of the interconnected loops, in turn, releases thecardiac harness 42 from the push rod 40.

The illustrated push rod 40 includes a plurality of throughholes, oropenings 62, 64 a-i, extending from an outward facing surface 40 a ofthe push rod 40 to an inward facing surface 40 b of the push rod 40. Inthe illustrated embodiment, ten openings 62, 64 a-i are provided,however, other numbers of openings may be provided to permit other typesand sizes of cardiac harnesses to be secured to the delivery device 30.Desirably, the opening 62 and the opening 64 a being less than the equalspacing between openings 64 a-i. Preferably, the space between theopenings 62 and 64 a is sufficient to accommodate the diameter of anindividual wire, which forms an uppermost row 66 a of the illustratedcardiac harness 42. In addition, preferably the remainder of theopenings 64 a-i are spaced from one another a distance substantiallyequal to a height of one row 66 b-h of the cardiac harness. Such anarrangement permits positioning of the wire of a single row 66 b-h ofthe cardiac harness 42 between each pair of openings 64 a-i.

Although the line 60 a is shown as being spaced from both the outwardfacing surface 40 a and inward facing surface 40 b in FIG. 5,preferably, the line 60 a is pulled tight after passing through theopenings 62, 64 a-i to secure the cardiac harness 42 directly againstthe inward facing surface 40 b of the push rod 40. The spacedorientation of the line 60 a depicted in FIG. 5 is merely for thepurpose of clearly illustrating the configuration of the releasablestitch.

In a preferred embodiment of the releasable stitch, a first end of theline 60 a is arranged into a slip knot 80, which defines a first loop 82a positioned on the outward facing surface 40 a side of the push rod 40.The slip knot 80 desirably is created near one end of the line 60 a suchthat, along with the first loop 82 a, a short end portion 83 of the line60 a is created. The remainder of the line 60 a is arranged intointerconnecting loops to create the releasable stitch, as is describedbelow.

The line 60 a passes through the distal most opening 62 to the inwardfacing surface 40 b side of the push rod 40. Preferably, the line 60 athen passes around the wire of the uppermost row 66 a of the cardiacharness 42 before passing through the opening 64 a back to the outwardfacing surface 40 a side of the push rod 40. Thus, between the openings62 and 64 a, the line 60 a creates a securing portion 84 a that holdsthe row 66 a of the cardiac harness 42 against the inward facing surface40 b of the push rod 40.

Once on the outward facing surface 40 a side of the push rod 40, theline 60 a passes through the first loop 82 a and is arranged to form asecond loop 82 b. Preferably, the second loop 82 b is large enough sothat it extends toward the proximal end of the push rod 40 a sufficientdistance to pass beyond the next adjacent opening 64 b. The line 60 athen passes back through the first loop 82 a and the opening 64 a to theinward facing surface 40 b side of the push rod 40. The line 60 acreates another securing portion 84 b, which secures a wire of a secondrow 66 b of the cardiac harness 42 to the push rod 40.

Preferably, in a similar manner, interconnected loops 82 c through 82 hare formed. Each of the loops 82 c-h are positioned on the outwardfacing surface 40 a side of the push rod 40 and correspond withrespective securing portions 84 c-84 h, which secure a respective wireof each row 66 c-h of the cardiac harness 42 against an inward facingsurface 40 b of the push rod 40. Although, preferably, each securingportion 84 a-h of the line 60 a secures a single row 66 a-h of thecardiac harness 42 to the push rod 40, in other configurations more orless than one row of the harness 42 may be secured by a single securingportion 84 a-h. Further, although in the illustrated embodiment, onehole 64 of the push rod 40 generally corresponds to one row 66 of theassociated harness 42, it is to be understood that, in otherembodiments, one row 66 may correspond with more or less than one hole64 and more or less than one securing portion 84.

In accordance with this arrangement, the cardiac harness 42 is securedto each push rod 40 at at least two longitudinally-spaced locations. Inthe illustrated embodiment, the harness 42 is secured to each push rod40 at eight longitudinally-spaced locations, or each of the eight rows66 a-h of the cardiac harness 42 is secured to each of the push rods 40.

Preferably, a proximal-most, or retaining, loop 86 a is arranged toinhibit the remaining loops 82 a-h from unraveling prematurely. In apreferred arrangement, the retaining loop 86 a passes through the nextdistal loop 82 h in a manner similar to the arrangement of loops 82 a-has described above. The retaining loop 86 a, however, has a sufficientlength to extend in a proximal direction along the push rod 40 to thecontrol assembly 38. Preferably, the loop 86 a passes through thelowermost opening 64 i to the inward facing surface 40 b side of thepush rod 40 and is extended along the push rod 40 in a proximaldirection. Within the control assembly 38, the loop 86 a is loopedaround a retaining rod 68 (shown schematically in FIG. 5).

The remaining end portion 100 a of the line 60 a, after forming theretaining loop 86 a, is passed through the loop 82 h and the opening 64h to the inward facing surface 40 b side of the push rod 40. The endportion 100 a of the line 60 a also extends in a proximal directionalong the push rod 40 and is tied off on the retaining rod 68. Thus, inthe illustrated arrangement, unravelment of the releasable stitch isprevented by the combination of the retaining loop 86 a being loopedaround the retaining rod 68, and the end portion 100 of the line 60 abeing tied onto, the retaining rod 68. Although shown tied onto theretaining rod 68, desirably, the end portion 100 is tied off onto areleasable portion of the control assembly 38, rather than the retainingrod 68 itself, as will be described in greater detail below.

In an alternative arrangement, the retaining loop 86.a may not be loopedaround the retaining rod 68, but may be inhibited from unraveling by analternatively suitable arrangement. For example, it is contemplated thatthe retaining loop 86 a may be formed approximately the same size as theremainder of the interconnected loops 82 a-h and may be tucked betweenthe adjacent loop 82 h and the outward facing surface 40 a of the pushrod 40. Thus, the retaining loop 86 a is inhibited from unraveling by africtional force of the adjacent loop 82 h holding the retaining loop 86a against the outward facing surface 40 a. When a sufficient pullingforce is applied to the end portion 100, the retaining loop 86 aovercomes the frictional force of the loop 82 h and the outward facingsurface 40 a and is drawn through the opening 64 h, thus permittingunraveling of the releasable stitch.

With reference next to FIGS. 6-9, a preferred embodiment of the controlassembly 38 is described in greater detail. As indicated above, thecontrol assembly 38 is movable axially relative to the shaft 34 of thedelivery device 30. Preferably, the control assembly 38 includes aposition-retaining arrangement, such as a friction brake assembly 102,for example. The friction brake assembly 102 is configured to permit thecontrol assembly 38 to be selectively retained in a desired positionrelative to the shaft 34. Preferably, the friction brake assembly 102 isconfigured to be easily actuatable, along with movement of the controlassembly 38, by one hand of a user of the device 30.

With particular reference to FIGS. 6 and 9, the illustrated frictionbrake assembly 102 includes a brake element 104 and a biasing member,such as a spring 106. The brake element 104 includes an annular centralportion 104 a surrounding the shaft 34. Opposing end portions 104 b, 104c extend in an outward direction from the central portion 104 asubstantially opposite from one another. The first end portion 104 b isretained within a channel 108 of the control assembly 38, preferably bya pin 110. The pin 110 is supported within cavities (not shown) of thecontrol assembly 38 on each side of the channel 108. Thus, the brakeelement 104 is pivotable generally about an outer surface of the pin110.

The spring 106 is retained within a cavity 111 and is arranged to biasthe second end 104 c of the brake element 104 away from the controlassembly 38. Preferably, the spring 106 biases the brake element 104such that an inner diameter-defining surface of the central portion 104a is in frictional contact with the shaft 34 so as to secure the controlassembly 38 in a desired position relative to the shaft 34. The brakeelement 104 may be pivoted toward the control assembly 38 by pushing theend 104 c toward the control assembly 38 to disengage the brake element104 from the shaft 34 and permit relative movement between the controlassembly 38 and the shaft 34. In another embodiment, two such brakeelements 104 are provided. However, each brake element is oriented topivot in an opposite direction. As such, one brake element betterprevents distal movement of the assembly relative to the shaft, and theother brake element better prevents proximal movement of the assemblyrelative to the shaft.

With particular reference to FIGS. 6 and 8, the control assembly 38preferably includes a substantially cylindrical body portion 112. Aplurality of passages, generally referred to by the reference numeral114, extend axially through the body portion 112 of the control assembly38. In the illustrated embodiment, the passages 114 are substantiallycylindrical in shape and are equally distributed in a circulararrangement coaxial with the shaft 34. Preferably, the passages 114 aregenerally aligned with corresponding channels 50 formed in the housing36.

A cover 116 is fixed to a proximal end of the body portion 112. Thecover 116 closes a proximal end of the passages 114 and the cavity 111.A plurality of fasteners, such as screws 118, engage correspondingthreaded apertures 120 (FIG. 7 a) of the body portion 112 to secure thecover 116 to the body portion 112.

With reference also to FIG. 7 a, in a preferred embodiment, the bodyportion 112 includes six passages 114, referred to specifically by thereference numerals 114 a-114 f. As a matter of convenience, the passages114 a-114 f are referred to herein by their relative positions asdepicted in FIGS. 7 a-c. As such, passages 114 a and 114 f comprise anupper pair of passages, passages 114 b and 114 e comprise a central pairof passages and passages 114 c and 114 d comprise a lower pair ofpassages. Passage 114 a is positioned to the right of a vertical axisA_(V) passing through the center of the shaft 34 in FIGS. 7 a and 7 b.The remaining passages 114 b-114 f are distributed in a clockwisedirection in an equally spaced relation to one another.

With particular reference to FIGS. 7 a and 8, each of theabove-described passages 114 a-f are configured to receive a proximalend of one of the push rods 40. The push rods 40 are secured withintheir respective passages 114 a-f by a shaft 150 passing through anopening (not shown) within the push rod 40 and being supported by thebody portion 112 of the control assembly 38. Thus, as described above,the push rods 40 are fixed for axial movement with the control assembly38.

In the illustrated embodiment, the push rods are supported generally inthe center of the passages 114 a-f, with their respective inner surfaces40 a arranged generally tangentially to the center axis of the shaft 34.In addition, with reference also to FIG. 10, a center portion 40 c ofeach push rod 40 is generally semicircular in cross-section such thatthe inward facing surface 40 a defines a recess 152. Preferably, therecess 152 is configured to accommodate one of the lines 60 a-f,respectively, as described above in relation to FIG. 5. As shown in FIG.10, the line 60 a consists of the retaining loop 86 a and the free end100 a, as is also described above in relation to FIG. 5.

With reference next to FIGS. 7 a-c, a plurality of channels, referred togenerally by the reference numeral 122, are defined by a proximal endsurface of the body portion 112 of the control assembly 38. Each of thechannels 122 interconnect two of the passages 114 a-114 f and areconfigured to accommodate a portion of one or more lines, such as theline 60 a, as is described in greater detail below. Specifically, in apreferred arrangement, a first channel 122 a extends generally parallelto the vertical axis A_(V) and interconnects the passages 114 a and 114c. Similarly, a second channel 122 b extends generally parallel to thechannel 122 a and interconnects the passages 114 d and 114 f Third andfourth channels 122 c, 122 d interconnect the passages 114 a and 114 band passages 114 b and 114 c, respectively. Similarly, fifth and sixthchannels 122 e, 122 f interconnect passages 114 f and 114 e and passages114 e and 114 d, respectively.

Preferably, each of the channels 122 a-f are arranged to generallyintersect a center of the passages 114 that they interconnect. Thechannels 122 a, 122 c and 122 d form a triangular shape on theright-hand side of the vertical axis A_(V). The channels 122 b, 122 eand 122 f form a triangular shape on the left-hand side of the verticalaxis A_(V), which shape is a mirror image of the triangular shapedefined by channels 122 a, 122 c and 122 d.

An additional channel 134 interconnects the passages 114 a and 114 f andextends in a direction generally parallel to a horizontal axis A_(H) asdepicted in FIGS. 7 a-c. The channel 134 is defined by a proximalsurface of the body portion 112 and, preferably, is substantially largerin both width and depth than the channels 122 a-f. Preferably, thechannel 134 has a width approximately one-half the diameter of thepassages 114 a, 114 f and is semicircular in cross-sectional shape.Desirably, the channel 134 passes approximately through the centers ofthe passages 114 a, 114 f.

The control assembly 38 also includes a release member 136 thatpreferably is configured to selectively release the releasable stitch,thereby releasing the cardiac harness 42 from the delivery device 30.With reference also to FIG. 9, a portion of the release member 136preferably is received within a cavity 137 of the body portion 112,which is located on an opposite side of the horizontal axis A_(H) fromthe channel 134. The cavity 137 defines a support surface 138 which,along with a corresponding portion of the distal surface of the cover116 (see FIG. 6), supports a portion of the release member 136.

Desirably, the retaining rod 68, illustrated schematically in FIG. 5,comprises a pair of rods 68 a,b that are part of the release member 136as shown in FIGS. 7 a-c and 9. The pair of rods 68 a,b extend outwardly(depicted vertically in FIGS. 7 a-c) from the release member 136 and areslidably received in corresponding bores 139 formed within the bodyportion 112 of the control assembly 38. Preferably, the bores 139 arespaced on opposing sides of the vertical axis A_(V). The rods 68 a,bpreferably are long enough such that distal end portions of the rods 68a,b pass through the channel 134.

The release member 136 defines a pull portion 140, which extends in anoutward direction away from the body portion 112. The pull portion 140preferably is generally annular in shape, such that a user of thedelivery device 30 can grasp the release member 136 with one or morefingers extending through a hole defined by the pull 140. It is to beunderstood that other suitable constructions may also be used to permita user of the device 30 to grasp and pull the release member 136 awayfrom the body portion 112, such as providing a pull tab, for example.

The release member 136 also includes a preferably trapezoidal shapedcavity 142 extending inwardly from an inward facing surface 144 of therelease member 136. The cavity 142 preferably is sized and shaped toavoid closing off the passages 114 c and 114 d.

The release member 136 preferably includes an attachment portion 146that extends from a wall of the cavity 142 and toward the body portion112. Preferably, the attachment portion 146 is arranged so that, asshown on FIGS. 7 b and 9, a space 147 is disposed between the attachmentportion 146 and the support surface 138 of the body portion 112. Asshown more particularly in FIG. 9, the attachment portion 146 preferablyis not as thick as the release member 136 and, desirably is about ¼ orless of the thickness of the release member 136. As shown particularlyin FIG. 9, an upper surface 149 of the attachment portion 146 preferablyis spaced 147 from the support surface 138 of the body portion 112.

With reference again to FIGS. 7 a-c and 8, the attachment portion 146preferably includes a plurality of holes 148 extending therethrough in adirection generally parallel to a longitudinal axis of the shaft 34. Inthe illustrated embodiment, there are six holes 148, one hole 148corresponding to each of the passages 114 a-f.

With particular reference to FIG. 7 b, the free ends 100 of the lines 60preferably are tied to corresponding holes 148 of the attachment portion146. As a more specific example, free end 100 a of line 60 a extendsdownwardly along the corresponding rod 40 (see FIG. 10) and enterspassage 114 a, from which it is directed into channel 122 a and into thecavity 142. The free end 100 a is then tied onto one of the holes 148 ofthe attachment portion 146. Thus, the free end 100 a of the line 60 a isaffixed to the release member 136.

The retention loop 86 a portion of line 60 a also extends downwardlyalong the corresponding rod 40 (see FIG. 10) and into the passage 114 a.From the passage 114 a the loop 86 a is directed into the channel 134and, as illustrated in FIG. 7 b, is looped about the right-most rod 68 aof the release member 136. Looping the retention loop 86 a around therod 68 a anchors the loop 86 a and thus prevents the line 60 a fromunraveling. Note that for convenience in illustration, the retentionloop 86 a, which actually comprises two portions of line as shown inFIG. 10, is illustrated in FIG. 7 b as a single line. This is done topresent a less-cluttered drawing.

The other free ends 100 b-f and retention loops 86 b-f preferably arearranged similarly, although they are customized for their respectivepositions in the device. For example, free end 100 b extends frompassage 114 b through channel 122 d into the cavity 142 and is affixedto a hole 148. Free end 100 c is directed directly from passage 114 cinto the cavity 142 and is affixed to a hole 148. Free end 100 d alsoextends directly from the passage 114 b into the cavity 142 and isaffixed to a hole 148. Free end 10 e extends out of passage 114 ethrough channel 122 f into the cavity 142 and is affixed to a hole 148.Free end 100 f extends from passage 114 f and through channel 122 b intothe cavity 142 and is affixed to a hole 148.

With regard to the retention loops 86, retention loop 86 b extends frompassage 114 b through channel 122 c into channel 134 and is loopedaround the right rod 68 a. Loop 86 c extends from passage 114 c throughchannel 122 a into channel 134 and is looped about the right rod 68 a.Retention loop 86 d extends from passage 114 d through channel 122 binto channel 134 and is looped about the left rod 68 b. Retention loop86 e extends out of passage 114 e through channel 122 e into channel 134and is looped about the left rod 68 b. Retention loop 86 f extends frompassage 114 f into channel 134 and is looped about the left rod 68 b.

In operation, the release member 136 is configured to release loops 86a-f, unravel the lines 60 a-f from the push rods 40 and thereby releasethe cardiac harness 42 from the push rods 40. More specifically, andwith reference to FIG. 7 c, as the release member 136 is pulled awayfrom the body 112 of the control assembly 38, the rods 68 a-b are alsopulled through the channel 134 such that the retention loops 86 a-f arereleased from the rods 68 a-b. Simultaneously, because the free ends 100a-f of the lines 60 a are tied onto one of the holes 148 of theattachment portion 146, the release member 136 pulls on the free ends100 a-f. Since the retention loops 86 a-f are released from the rods 68a-b, pulling of the free ends 100 a-f unravels the lines 60 a-f, therebyreleasing the cardiac harness 42 from the push rods 40, as is describedfurther below in connection with FIGS. 11 a-c.

FIGS. 11 a through 11 c illustrate a preferred sequence of unravelmentof the releasable stitch of line 60 a. With additional reference to FIG.5, as described above, in a secured position of the releasable stitch,preferably the retaining loop 86 a is looped around the rod 68 of therelease member 136 to inhibit unravelment of the stitch. However, whenthe rod 68 is retracted to release the retaining loop 86 a, and the freeend 100 a is pulled by the release member 136, the retaining loop 86 ais pulled through the loop 82 h by the free end 100 a.

Returning to FIG. 11 a, as the release member 136 continues to be pulledaway from the main body 112 of the control assembly 38, the loop 82 h ispulled through the loop 82 g in a manner similar to that describedabove. With reference to FIG. 11 b, as the free end 100 a continues tobe pulled, each successive loop 82 g, 82 f, 82 e, 82 d, 82 c, 82 b, 82 ais pulled through its distally-adjacent loop. In FIG. 11 b, loop 82 e isillustrated as being pulled through loop 82 d. Subsequently, loop 82 dis pulled through loop 82 c, which is then pulled through loop 82 b.Finally, loop 82 b is finally pulled through the initial loop 82 a, asillustrated in FIG. 12 c.

The initial loop 82 a, which preferably comprises a slip knot 80,preferably completely unties itself and is pulled through thedistal-most opening 62 to release the cardiac harness 42 from the pushrod 40. In a similar manner, because the remainder of the lines 60 b-fare also secured to the release member 136, the cardiac harness 42preferably is simultaneously released from each of the plurality of pushrods 40.

With next reference to FIG. 12, a distal end of one of the plurality ofpush rods 40 is shown in section. As described above, the push rod 40has an inward facing surface 40 b, which faces a center axis of shaft34, and an outward facing surface 40 a, which faces away from a centeraxis of the shaft 34. Thus, in operation, the inner surface 40 b of eachof the push rods 40 is positioned adjacent to, and preferably in contactwith, the cardiac harness 42.

The distal end of the push rod 40 includes a tip portion 154 that, in apreferred arrangement, is canted outwardly away from a center axis ofthe shaft 34. Thus, the inner surface 40 b of the tip portion 154defines an angle θ with respect to a line 156 extending from the innersurface 40 b of the remainder of the push rod 40. In a preferredarrangement, the angle θ is between about 5-60 degrees, and morepreferably is between about 10-45 degrees. Most preferably, the angle isbetween about 15-35 degrees.

As will be appreciated by one of skill in the art, although preferablythe inner surface 40 b is generally planar in a relaxed orientation, thepush rod 40 is configured to be deflectable so as to splay outwardlyfrom a distal end of the housing 36 so as to conform to an outer surfaceof a patient's heart while in use. Accordingly, the push rod 40 is notalways oriented such that the inner surface 40 b is necessarily planar.However, when the push rod 40 is in a splayed orientation, any givenpoint on the surface 40 b preferably is either the same perpendiculardistance from a center axis of the shaft 34, or a greater distance, thanany point on the surface 40 b proximal to the given point. That is,preferably, the inward facing surface 40 b does not have any inwardlyextending portions when moving from a proximal end of the push rod 40toward a distal end of the push rod 40.

In operation, once the cardiac harness 42 has been positioned on apatient's heart, the control assembly 38 is retracted relative to theshaft 34 such that the plurality of push rods 40 are also retractedrelative to the cardiac harness 42. Upon retraction of the deliverydevice 30, relative motion is experienced between the inner surface 40 band the cardiac harness 42. That is, the inner surface 40 b of the pushrod 40 slides along the cardiac harness 42 along a withdrawal path in awithdrawal direction W_(D), as indicated by the arrow in FIG. 12.

Preferably, the tip 154 is configured with an angle such that uponsliding motion of the push rod 40 relative to the cardiac harness 42, noforce is exerted by the inner surface 40 b tending to drag the cardiacharness 42 from its position on the heart. That is, the construction ofthe inward facing surface 40 b of the push rods 40 is such thatnon-frictional force components parallel to the withdrawal path andattributable to forces exerted by the inner surface 40 b on the cardiacharness 42 are directed distally, without substantial non-frictionalforce components directed proximally, or in the withdrawal directionW_(D). Advantageously, once the cardiac harness 42 is properlypositioned on the heart, retraction of the push rods 40 does not disturbthe positioning of the harness 42.

With next reference to FIGS. 13-17, an introducer assembly 160 assistsin creating an access opening in the pericardium of a patient's heart topermit access of the delivery device 30 to the heart. In the illustratedembodiment, the introducer assembly 160 includes an introducer sleeve162 and a dilator sleeve 164.

With particular reference to FIG. 13, the introducer sleeve 162preferably is a thin-walled, tubular element having a substantiallycircular cross-sectional shape. A distal end 163 of the sleeve 162comprises a plurality of flared portions 165 that are biased outwardlyfrom a longitudinal axis As of the sleeve 162. In the illustratedembodiment, a portion of the sleeve 162 is divided into several elongatestrips 166. Preferably, the elongate strips 166 are spaced apart fromeach other. In a preferred arrangement, about the distal-most ⅔ of thelength of the introducer sleeve 162 is divided into the spaced apartelongate strips 166. Preferably, six such strips 166 are provided.However, other suitable numbers of strips may also be used.

With continued reference to FIG. 13, the strips 166 preferably extendgenerally parallel to the longitudinal axis As of the sleeve, exceptthat at the distal end of each strip, a flared portion 165 is biasedgenerally outwardly. Preferably, the strip 166 bends at a transitionportion 167 to transition from the generally straight portion of thestrip to the flared portions 165. In the illustrated embodiment, theflared portions 165 also extend somewhat in a direction generallytransverse to the longitudinal axis A_(S).

Preferably, a resilient annular member, such as an elastic ring 168, ispositioned toward the distal end 163 of the introducer sleeve 162 at oradjacent the transition portions 167 of the elongate strips 166.Desirably, the elastic ring 168 is configured to bias the strips 166into a reduced-diameter portion, which is operable to ease insertion ofthe introducer sleeve 162 into an incision in the pericardium, as isdescribed in greater detail below.

With particular reference to FIG. 14, the dilator sleeve 164 preferablyis a thin-walled, tubular member, which is also substantially circularin cross-section. An outer diameter of the dilator sleeve 164 isconfigured to be slightly smaller than an inner diameter of theintroducer sleeve 162. Accordingly, the dilator sleeve 164 may beslidably inserted within the introducer sleeve 162, as illustrated inFIG. 15. The dilator sleeve 164 may also have an enlarged diameterportion 170 on its proximal most end to limit the insertion within theintroducer sleeve 162. Further, a releasable locking system may beprovided so that the dilator sleeve 164 may be releasably engaged withthe introducer sleeve 162.

In the assembled condition illustrated in FIG. 15, the dilator sleeve164 presses against an inner surface of the reduced-diameter portion ofthe introducer sleeve 162 to force the reduced-diameter portion outwardagainst the biasing force provided by the elastic ring 168. Thus, in theassembled configuration, the reduced diameter portion of the introducersleeve 162 is enlarged and the introducer assembly 160 is configured toprovide an access pathway for the delivery device 30. Preferably, aninner diameter of the sleeve 164 is greater than an outer diameter ofthe delivery device 30 so that the device can be advanced through thesleeve 164.

FIG. 16 illustrates a human heart 172, which is enclosed within apericardium 174. To permit introduction of the delivery device 30 towithin the pericardium 174, preferably, a small incision 176 is made inthe pericardium 174 adjacent the apex of the heart. With reference nextto FIG. 17, the introducer sleeve 162, in its contracted orientation, isintroduced into and through the incision 176. In practice, one side ofthe distal end of the introducer sleeve 162 may be inserted into theincision 176 first, followed by the remaining side.

With reference next to FIG. 18, once the flared portions 165 of theintroducer sleeve 162 have been advanced through the slit 176, thedilator sleeve 164 is then introduced within the introducer sleeve 162to urge the introducer sleeve 162 into its expanded configuration. Inthis configuration, the flared portions 165 are expanded to a diametergreater than the diameter of the rest of the introducer sleeve 162 andpreferably greater than the size of the incision 176. As such, theflared portions 165 press upon and open the incision 176 and thesurrounding portion of the pericardium so as to create a space betweenat least part of the pericardium and the heart. Further, the flaredportions 165 function as a lock to resist pulling the introducer out ofthe incision 176. Accordingly, the introducer assembly 160 iseffectively locked in place between the heart 172 and the pericardium174.

Since the dilator sleeve 164 dilates the introducer sleeve 162, anaccess pathway is created to allow the delivery device 30 to be advancedtherethrough and through the pericardium. The delivery device 30 isadvanced through the pathway so as to deliver the cardiac harness 42onto the heart 172. When the procedure is completed, the delivery device30 is retracted through the access pathway and the introducerarrangement 160 is removed in generally the reverse order of theinsertion.

As discussed above, in an additional embodiment the housing 36 isgenerally elliptical. It is to be understood that, in still furtherembodiments, the introducer sleeve 162 and dilator sleeve 164 are alsoelliptical, having a major axis and a minor axis. Further, each of thesecomponents may have any desired cross-sectional shape. As such, they mayhave a shape that is customized for any desired type or shape ofminimally invasive surgical entry path.

FIGS. 19-23 illustrate the use of a delivery device 30, preferablyconfigured substantially as described above, to deliver a cardiacharness 42 onto a heart 172. Preferably, the delivery device 30 isconfigured to locate and grasp the heart 172, accurately position thecardiac harness 42 onto the heart 172, and permit withdrawal of thedelivery device 30 without disturbing the positioning of the cardiacharness 42.

With reference to FIG. 19, preferably, the suction cup 52 of thedelivery device 30 engages an apex portion 180 of the heart 172, whichis illustrated schematically in FIGS. 19-23. The distal end of thedelivery device 30 may access the heart 172 through any suitable method,but preferably through a minimally invasive procedure such as thatdescribed in relation to FIGS. 16-18. In FIGS. 19-23, the pericardium174 (FIG. 16) is omitted to ease illustration.

A pump device, such as a syringe 182, is connected to the hose 54through the connector 58. Desirably, the syringe 182 is connected to thehose 54 with the plunger 184 in a compressed position. Once connected,the plunger 184 is retracted (as indicated by the arrow 185 in FIG. 19)to create a vacuum condition within the hose 54 and, thus, within thespace defined by the interior of the suction cup member 52. Due to thevacuum condition, the suction cup member 52 grasps the apex 180 suchthat the heart 172 is held in a desired position relative to thedelivery device 30.

Preferably, the connector 58 includes a one-way valve 59 that isconfigured to inhibit air from flowing from the syringe to the tube 54through the connector 58. Accordingly, the syringe 182 may be removedfrom the tube 54 once a vacuum condition has been created. Although asyringe 182 is preferred as a pump member due to its simplicity and lowcost, other suitable pump devices may also be used to create a vacuumwithin the tube 54, as will be appreciated by one of skill in the art.

With reference next to FIG. 20, once the delivery device 30 has beenproperly secured to the base 180 of the heart 172, the control assembly38 may be advanced, relative to the shaft 34, toward the heart 172, asindicated by the arrow 186 in FIG. 20. The plurality of push rods 40 areadvanced toward the heart 172 with the control assembly 38 therebyadvancing the cardiac harness 42 from its compacted configuration withinthe housing 36 onto the heart 172 in a direction from the base 188 tothe apex 180, as indicated by the arrow 190 in FIG. 20. As shown, theharness 42 preferably stretches elastically to fit over the heart.However, it is to be understood that a substantially non-elastic harnessembodiment can also be delivered by this device and method.

As illustrated in FIG. 20, the plurality of push rods 40 splay outwardlyto conform to the shape of the heart 172 as they are advanced relativeto the shaft 34 of the delivery device 30. As described above,preferably the tips 154 of the push rods 40 are canted at an outwardangle θ relative to the remainder of the push rod 40 such that contactof the tip 154 with the heart 172 is generally avoided, therebypreventing trauma to the heart 172.

With reference to FIG. 21, the control assembly 38 continues to beadvanced until the cardiac harness 42 is properly positioned on theheart 172. Once the cardiac harness 42 is properly positioned, therelease member 136 is pulled away from the main body 112 of the controlassembly 38, as indicated by the arrow 192. Accordingly, the cardiacharness 42 is released from the plurality of push rods 40, preferably ina manner similar to that described above with reference to FIGS. 11 a-c.

With reference to FIG. 22, once the cardiac harness 42 has been releasedfrom the plurality of push rods 40, the generally-elastic harnesspreferably contracts onto the heart. The control assembly 38 is thenretracted relative to the shaft 34 to retract the plurality of push rods40 from the cardiac harness 42, which remains on the heart 172. As notedabove, preferably, the push rods 40 are configured such that retractionof the push rods 40 does not tend to pull the cardiac harness 42 fromits desired position on the heart 172. Specifically, in the illustratedembodiment, the outwardly canted tips 154 of the plurality of push rods40 help prevent the push rods 40 from exerting a pulling force on thecardiac harness 42.

With reference to FIG. 23, once the plurality of push rods have beenfully retracted from the cardiac harness 42 and the heart 172, theone-way valve 59 within the connector 58 may be opened to release thevacuum condition with the tube 54. As a result, the delivery device 30may be removed from the heart 172, as indicated by the arrow 194 in FIG.23, as the suction cup member 52 is no longer grasping the heart 172.Thus, the delivery device 30 is retracted from the heart, leaving thecardiac harness 42 in place.

As discussed above, the delivery device 30 holds the cardiac harness 42at several spaced apart locations. As such, the device exerts adistributed hold on the harness 42. Due to the distributed hold, thedevice can be used to advance the harness 42 as discussed above and alsocan be used to adjust the positioning and orientation of the harnesswithout substantially deforming the harness 42. For example, if theharness is advanced distally farther than desired, the control assembly38 can be pulled proximally somewhat in order to fine tune the positionof the harness relative to the heart. Due to the distributed holdbetween the device 30 and the harness 42, the harness will moveproximally as desired without substantial deformation, such as foldingover itself or the like. Furthermore, in another embodiment, theposition of the harness can be adjusted not only distally and proximallybut also rotationally without substantially deforming the harness.

Although the delivery device 30 is especially well suited for use in aminimally invasive delivery procedure, the device 30 may also be usedfor open chest procedures, wherein the sternum of the patient is splitto provide access to the heart 172. Accordingly, the delivery device 30may be used with or without the delivery arrangement illustrated inFIGS. 13-18. In addition, although the device 30 described hereinutilizes a plurality of push rods 40, other suitable structures may alsobe used as support structures to support the cardiac harness 40, whenbeing advanced over the heart. For example, an expandable sleeve canserve as a support structure. Furthermore it is to be understood that acardiac harness 42 may be releasably supported in an expanded, orsubstantially expanded, configuration to a variety of support structuresby the releasable stitch described herein, or by a similar releasablestitch arrangement.

With reference next to FIGS. 24-27, an embodiment of a cardiac harnessloading device 200 is illustrated. The loading device 200 is configuredto cooperate with the delivery device 30 to support the plurality ofpush rods 40 in an outwardly splayed orientation so that the cardiacharness 42 may be secured to the push rods 40. The loading device 200may also be useful to assist in urging the cardiac harness 42 from anexpanded or at rest configuration to a compacted configuration, so as tobe insertable into the housing 36 of the delivery device 30.

The illustrated loading device 200 is generally funnel shaped, having acone-shaped upper portion 202 extending upwardly from a generallycylindrical lower portion 204. The lower portion 204 includes a pocket206, which is configured to receive a distal end of the delivery device30, and more specifically the suction cup member 52. In a preferredembodiment, however, the suction cup is removed while the harness isloaded, and is attached after the loading of the harness is complete.

Preferably, the loading device 200 is a thin-walled hollow member and,in the illustrated embodiment, is constructed from a pair of mirrorimage halves 200 a, 200 b (FIG. 26) coupled to one another by a pair ofpinned flanges 205 a, 205 b. That is, a pin 207 extends through a cavityextending through each half 200 a, 200 b within each flange 205 a, 205b, thereby securing the halves 200 a, 200 b to one another. It is to beunderstood that the halves 200 a, 200 b may be coupled in any manner. Inan additional embodiment, the loading device comprises a single member.

With particular reference to FIGS. 25 and 26, a plurality of channels208 preferably extend upwardly from the pocket 206 and terminate at theopen, upper end of the cone-shaped upper portion 202. Desirably, each ofthe channels 208 is shaped to receive one of the plurality of push rods40 and, preferably, are shaped generally complementary to the shape ofthe push rods 40. Therefore, desirably, the number of channels 208provided is equal to the number of push rods 40 present in the deliverydevice 30. Thus, each channel 208 is configured to receive and positionone of the plurality of push rods 40 in an appropriate splayed positionsuch that the cardiac harness 42 may be releasably secured thereto.

A lower portion 208 a of each channel 208 preferably is substantiallyparallel to a center axis of the delivery device 30 when the distal endof the device 30 is positioned within the pocket 206 of the loadingdevice 200. An upper portion 208 b of the channel 208, correspondingwith the upper portion 202 of the loading device 200, preferably issplayed in an outward direction relative to the lower portion 208 a.Thus, when received within the upper portion 208 b of the channels 208,the push rods 40 preferably are oriented in a splayed configuration,similar to the position assumed when the push rods 40 are positionedover a heart.

Desirably, the loading device 200 includes a plurality of cut outportions 210 corresponding with an elongate portion of each upperportion 208 b of the channels 208. Preferably, the cut out portions 210are disposed on an outer surface of the loading device 200 and expose anelongate portion of a push rod 40 disposed in the upper portion 208 b ofthe channel 208 (see FIG. 27). In addition, preferably the entirechannel 208 is open toward an inner surface of the loading device 200.Desirably, the cut out portions 210 correspond with a portion of thecorresponding push rods 40 in which the through holes 62, 64 a-i (FIG.5) are provided. As such, the loading device 200 secures the push rods40 in a splayed orientation with the through holes 62, 64 a-i exposed sothat the cardiac harness 42 may be releasably secured to each of thepush rods 40 by a releasable stitch.

FIG. 27 illustrates a cardiac harness 42 disposed in the loading device200 along with and adjacent the push rods 40. In the illustratedarrangement, the harness 42 is ready to be secured to the push rods 40.

With reference next to FIGS. 28 a-c, a preferred method for creating thereleasable stitch from a line 60 a is illustrated. With reference toFIG. 28 a, the cardiac harness 42 preferably is positioned relative tothe push rod 40 such that an upper most row 66 a of the harness 42 ispositioned between through holes 62 and 64 a of the push rod 40, or thetwo uppermost through holes. The line 60 a is passed along the inwardfacing surface 40 b of the push rod 40 in an upward directionpositioning the cardiac harness 42 between the line 60 a and the surface40 b of the push rod 40. An upper end of the line 60 a is passed throughthe through hole 62 and, preferably, formed into a slip knot 80, whichforms the initial loop 82 a of the releasable stitch.

With reference to FIG. 28 c, preferably an instrument, such as a hook220 is passed through the loop 82 a and grasps a portion of the line 60a below the upper row 66 a of the cardiac harness 42. The line 60 a ispulled through the through hole 64 a and through the initial loop 82 a,to secure the upper row 66 a of the cardiac harness 42 to the push rod40. With reference to 28 c, the line 60 a is pulled further through theloop 82 a to create the second loop 82 b. This process is repeated untileach of the rows 66 a-h are secured to each of the plurality of pushrods 40. With reference again to FIG. 5, the final loop, or retentionloop 86 a, preferably is retained by the rod 68 a of the release member136, as previously described. In addition, preferably the end 100 a ofthe line 60 a is tied off on the release member 136, as also describedabove.

With reference again to FIG. 27, once the cardiac harness 42 isreleasably secured to each of the push rods 40, the control assembly 38may be retracted relative to the shaft 34 to retract the push rods 40and, thus, retract the cardiac harness 42 into its compactedconfiguration within the housing 36 of the delivery device 30 (asillustrated in FIG. 2). As described above, the funnel shape of theupper portion 202 and the cylindrical shape of the lower portion 204 ofthe loading device 200 assist in urging the cardiac harness 42 from itsexpanded configuration into its compacted configuration.

With reference next to FIGS. 29-32, another embodiment of a controlassembly 238 and associated push rods 240 is illustrated. In theillustrated embodiment, the control assembly 238 comprises a bodyportion 242 and a handle portion 244 which are configured to slideaxially over the shaft 34.

With particular reference to FIG. 29, the body portion 242 includes afirst and a second friction brake assembly 246, 248. Preferably, eachfriction brake assembly 246, 248 is constructed in a manner similar tothe assembly 102 described above in connection with FIGS. 6-9. However,the pivoting direction and orientation of the brake element 104 portionin the first brake assembly 246 is reversed relative to such orientationin the second brake assembly 248. As such, axial movement of the controlassembly 238 over the shaft 34 can be selectively inhibited in either adistal or proximal direction by selectively engaging the first or secondbrake assembly 246, 248.

With particular reference to FIGS. 30-32, the elongate push rod 240includes a plurality of through holes, or openings 262, 264 extendingtherethrough. The push rod 240 is configured to accept a releasablestitch such as that discussed above in connection with FIG. 5 and aswill be discussed below in connection with FIG. 33. Preferably, the pushrod is constructed of a radiopaque material.

With more particular reference to FIG. 31, a distal tip 249 of the pushrod 240 comprises a generally barrell-shaped atraumatic tip portion 260.It is to be understood, however, that the atraumatic tip 260 can beshaped in several different ways in order to minimize the likelihoodthat the tip will puncture, scratch or otherwise traumatize tissue. Forexample, the tip can be folded over, be generally teardrop shaped, or begenerally cylindrical.

With particular reference next to FIGS. 30 and 32, a proximal region 266of the push rod 240 comprises a plurality of ribs 270 attached to aspine 271 of the rod 240. The ribs 270 extend outwardly and function toincrease the rigidity of the rod in the proximal region 266. An elongatepassage 272 is formed between the ribs, and defines a line path 272configured to accommodate a line 60 a extending therethrough. The ribs270 increase the rigidity of the push rod 240 in the proximal region266. As such, the push rod 240 is more flexible in a distal region 273than in the proximal region 266. It is to be understood that, in otherembodiments, further structural or material strategies can be used tofurther vary the flexibility of push rods along their length.

In the illustrated embodiment, the ribs 270 do not extend all the way toa proximal end 274 of the push rod 240. At or near the proximal end, apair of cutouts 276 are formed at opposite sides of the push rod.

With reference again to FIGS. 29 and 30, a series of passages 250 areformed in the body 242 of the control assembly 238. Each passage 250comprises a rod portion 252 and a line portion 254. The rod portions 256are configured so that the proximal end 274 of each push rod 240 fitsinto the rod portion 252 of the passage 250. The line portions 254generally align with the line path 272 between the ribs 210 of theinstalled push rod 240, and thus provides a passage for the line 60 a totravel into the control assembly 238. A pair of pin passages 256 areformed in the control assembly corresponding to each rod passage. Thepin passages 256 are configured to generally align with the cutouts 276at the proximal end 274 of each push rod 240. Locking pins 258 (see FIG.34) are inserted into the pin passages 256 and through the cutouts 276in order to support the push rod 240 in place in the control assembly238.

With reference next to FIG. 33, another arrangement for releasablyholding a harness 42 onto a push rod 40 is illustrated. This embodimentis quite similar to the embodiment discussed above in connection withFIG. 5, in that several interconnected loops 82 a-h are arranged tocreate securing portions 84 a-h of a line 60 a in order to engage andsecure rows 66 a-h of the cardiac harness 42 to secure the harness ontothe push rod 40. In the illustrated embodiment, a proximal-most loop,referred to as a free loop 280, extends along an outer surface 40 a ofthe push rod 40 proximal of a proximal-most throughhole 64 i. Aretaining loop 282 portion of the line 60 a extends from the innersurface-40 b of the push rod 40 through the hole 64 i and loops aboutthe free loop 280. From the retaining loop 282, an end portion 100 a ofthe line 60 a extends to the release member 68. Tension in the line 60 aholds the free loop 280 in place, and a friction force resists drawingof the free loop 280 through the retaining loop 282 in order to releasethe releasable stitch. Further, in this arrangement, only a single line60 a is drawn down through the line path 272 and into the controlassembly 38 or 238.

With continued reference to FIG. 33, once the harness 42 is in placeupon a patient's heart, the release member 68 is actuated in order topull the line 60 a. As such, the retaining loop 282 engages and pulls onthe free loop 280. This interaction between the loops 280, 282 createsfrictional resistance; however, upon continued pulling by the clinician,the frictional resistance is overcome and the retaining loop 282 isdisengaged from the free loop 280, at which point the releasable stitchdisengages in the same manner as discussed above with reference to FIGS.11 a-c.

In the illustrated embodiment, the push rod 40 resembles the push rod 40presented in FIG. 5. It is to be understood that the just-discussedembodiment can also be employed in connection with a push rod 240 asdepicted in FIGS. 30-32, or with any suitable push rod.

With reference next to FIG. 34, an interior view of the control assembly238 of FIG. 29 is shown. In this embodiment, the line and stitchingarrangement of FIG. 33 is employed. As such, only a single line 100 aextends into the control assembly 238 from each push rod 240, and noloop extends into the control assembly 238. An end of each line 100 a-fis tied onto the release member 268. As shown in FIG. 34, (channels 284a,b, 286 a,b extend between each control assembly passage line portionto the release member 268 in order to accommodate each line 100 a-f. Thelines 100 a-f associated with each push rod 240 extend through theassociated channels 284 a,b, 286 a,b to the release member 268. As such,when the release member 268 is pulled outwardly, the lines 100 a-f arepulled so as to release the loops holding the harness 42 onto the pushrod.

In the embodiments disclosed herein, the illustrated cardiac harness 42is formed of several rows of elastic elements. The illustrated harnesscomprises undulating wire arranged in several adjacent rings, each ofwhich comprises an elastic row. As illustrated, the harness 42 isreleasably attached to the push rods by a stitch being wound around someor all of the rows. Of course, it is to be understood that aspects ofthe present invention can be employed with harnesses having differentstructure than the illustrated harness, which is included for exampleonly. For example, any harness having one or more openings that couldaccommodate the releasable stitch could be used such as, for example, aharness formed of a woven or non-woven fibrous material and/or a harnessformed of a mesh, honeycomb or other type of material.

Although the present invention has been described in the context of apreferred embodiment, it is not intended to limit the invention to theembodiment described. Accordingly, modifications may be made to thedisclosed embodiment without departing from the spirit and scope of theinvention. For example, any of a variety of suitable releasablestitches, or other releasing mechanisms, may be used. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments discussed herein may bemade. Accordingly, various features and aspects of the disclosedembodiments can be combined with or substituted for one another in orderto form varying modes of the invention. In addition, although theillustrated device 30 is well suited for delivering a cardiac harnessthrough a minimally invasive procedure, the illustrated device 30, oralternative arrangements thereof, may also be used in an open chestprocedure. Accordingly, the invention is intended to be defined only bythe claims that follow.

1-25. (canceled)
 26. An apparatus for creating a passage through thepericardium of a patient to permit access of a cardiac harness deliverydevice to the heart, comprising: an introducer sleeve having an outerwall defining a proximal end and a distal end, the outer wall having areduced-diameter portion adjacent to the distal end, thereduced-diameter portion defining a reduced orientation having a firstdiameter, the distal end being sized to be insertable through anincision in the pericardium of the heart; and a dilator sleeve, thedilator sleeve being sized and shaped to be insertable into theintroducer sleeve to dilate the reduced-diameter portion into anexpanded orientation having a second diameter, larger than the firstdiameter, the second diameter being of a size sufficient to permit thecardiac harness delivery device to pass therethrough.
 27. An apparatusfor creating a passage through the pericardium of a patient to permitaccess of a cardiac harness delivery device to the heart, comprising: anintroducer sleeve having an outer wall defining a proximal end and adistal end, the outer wall having a reduced-perimeter portion adjacentto the distal end, the reduced-perimeter portion defining a reducedorientation having a first perimeter, the distal end being sized to beinsertable through an incision in the pericardium of the heart; and adilator sleeve, the dilator sleeve being sized and shaped to beinsertable into the introducer sleeve to dilate the reduced-perimeterportion into an expanded orientation having a second perimeter, largerthan the first perimeter, the second perimeter being of a sizesufficient to permit the cardiac harness delivery device to passtherethrough.
 28. The apparatus of claim 27, additionally comprising areleasable lock for releasably engaging the dilator sleeve within theintroducer sleeve.
 29. The apparatus of claim 27, wherein the introducersleeve is a thin-walled tubular element having a substantially circularcross-sectional shape.
 30. The apparatus of claim 27, additionallycomprising a biasing member surrounding the outer wall of the introducersleeve, the biasing member being configured to bias thereduced-perimeter portion into the reduced orientation.
 31. Theapparatus of claim 30, wherein the biasing member comprises an elasticring.
 32. The apparatus of claim 27, wherein the outer wall of theintroducer sleeve comprises a plurality of cut out portions extendingparallel to a longitudinal axis of the outer wall, the cut out portionsextending at least through the reduced-perimeter portion of the outerwall.
 33. The apparatus of claim 27, wherein the introducer sleeve has aplurality of elongate strips, the elongate strips extending from thedistal end of the introducer sleeve through the reduced-perimeterportion.
 34. The apparatus of claim 33, wherein the elongate stripsextend about the distal-most two-thirds of the length of the introducersleeve.
 35. The apparatus of claim 33, wherein the elongate strips haveflared portions at the distal end, the flared portions biased outwardlyfrom a longitudinal axis of the introducer sleeve.
 36. The apparatus ofclaim 35, wherein the elongate strips are spaced apart from each other,the flared portions at the distal end widen in a direction generallytransverse to a longitudinal axis of the introducer sleeve.
 37. Theapparatus of claim 27, wherein the reduced orientation comprises theouter wall at the distal end of the introducer sleeve having a distalperimeter greater than the first perimeter at the reduced-perimeterportion of the introducer sleeve, the distal perimeter being sized topermit the distal end to engage the interior surface of the pericardiumsurrounding the incision.
 38. The apparatus of claim 27, wherein theexpanded orientation comprises the outer wall at the distal end of theintroducer sleeve having a distal perimeter greater than the secondperimeter at the reduced-perimeter portion of the introducer sleeve, thedistal perimeter being sized to permit the distal end to contact theinterior surface of the pericardium surrounding the incision.
 39. Theapparatus of claim 27, wherein the dilator sleeve is a thin-walledtubular element having a substantially circular cross-sectional shape.40. The apparatus of claim 27, wherein the dilator sleeve has an innerperimeter greater than an outer perimeter of the cardiac harnessdelivery device, thereby permitting the cardiac harness delivery deviceto be advanced therethrough.
 41. The apparatus of claim 27, wherein thedilator sleeve has a distal portion, the distal portion having an outerperimeter, the proximal end of the introducer sleeve having an innerperimeter slightly greater than the outer perimeter of the distalportion of the dilator sleeve, thereby permitting the dilator sleeve tobe advanced within the introducer sleeve.
 42. The apparatus of claim 41,wherein the outer perimeter of the distal portion of the dilator sleeveis greater than the first perimeter of the reduced-perimeter portion ofthe introducer sleeve, thereby permitting the dilator sleeve to dilatethe reduced-perimeter portion.
 43. The apparatus of claim 27, whereinthe dilator sleeve has a proximal portion and a distal portion, theproximal portion having an enlarged perimeter portion relative to thedistal portion, the proximal end of the introducer sleeve having aninner perimeter smaller than the perimeter of the enlarged perimeterportion, thereby limiting advancement of the dilator sleeve within theintroducer sleeve.
 44. An apparatus for creating a passage through thepericardium of a patient to permit access of a cardiac harness device tothe heart, comprising: an introducer sleeve having a narrowing distalportion relative to the proximal portion, the distal portion having aplurality of elongate strips, the elongate strips having flaredportions, the flared portions positioned at a distal end of theintroducer sleeve for engaging an incision in the pericardium of theheart; and a dilator sleeve, the dilator sleeve having an inner wall andan outer wall, the outer wall perimeter being sized to permit thedilator sleeve to slide within the introducer sleeve for deflecting theelongate strips of the introducer sleeve, the inner wall perimeter beingsized to permit a cardiac harness delivery device to pass therethrough.45. An apparatus for creating a passage through the pericardium of apatient to permit access of a cardiac harness device to the heart,comprising: an introducer sleeve, the introducer sleeve having acontracted distal end, the distal end having a plurality of flaredportions for engaging an incision in the pericardium of the heart; and adilator sleeve, the dilator sleeve having an inner wall and an outerwall, the outer wall perimeter being sized to permit the dilator sleeveto slide within the introducer sleeve for expanding the distal end ofthe introducer sleeve, the inner wall perimeter being sized to permit acardiac harness delivery device to pass therethrough.
 46. A method forcreating a passage through the pericardium of a patient to permit accessof a cardiac harness delivery device to the heart, comprising: making anincision in the pericardium; introducing through the incision a distalend of an introducer sleeve having a reduced orientation; and dilatingthe distal end of the introducer sleeve into an expanded orientationthereby dilating the incision to a size sufficient to permit access of acardiac harness delivery device to the heart.
 47. The method of claim46, wherein making the incision comprises sizing the incision smallerthan the perimeter of the distal end of the introducer sleeve in thereduced orientation.
 48. The method of claim 46, wherein introducing theintroducer sleeve comprises: positioning the distal end of theintroducer sleeve adjacent to the incision; inserting through theincision a first portion of the distal end of the introducer sleeve;inserting through the incision a second portion of the distal end of theintroducer sleeve; and advancing the first portion and the secondportion of the introducer sleeve through the incision to engage aninside edge of the incision.
 49. The method of claim 48, whereinpositioning the distal end of the introducer sleeve comprises advancingthe distal end through a minimally invasive pathway to the pericardium.50. The method of claim 46, wherein dilating the introducer sleeve intothe expanded orientation comprises: introducing a dilator sleeve withinthe introducer sleeve to dispose the dilator sleeve against areduced-perimeter portion of the introducer sleeve; advancing thedilator sleeve to overcome a biasing force exerted on thereduced-perimeter portion; and further advancing the dilator sleeve intothe reduced-perimeter portion of the introducer sleeve so that thedistal end of the introducer sleeve expands to dilate the incision to aperimeter equal to or greater than the perimeter of the cardiac harnessdelivery device.
 51. The method of claim 50, further comprising:advancing the dilator sleeve through the reduced-perimeter portion ofthe introducer sleeve so that the distal end of the introducer sleeveexpands to push the interior surface of the pericardium surrounding theincision away from the heart; engaging the dilator sleeve within theintroducer sleeve so that the flared portions remain expanded when thedilator sleeve is released by the doctor.
 52. The method of claim 51,further comprising pulling the introducer sleeve slightly in a proximaldirection to lift a portion of the pericardium surrounding the incisionaway from the heart to create a space.